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STERILIZATION HEALTHCARE

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STERILIZATION HEALTHCARE Steam Sterilizers Operation and Preventative Maintenance * * * * * * * * * Where would you find hardness standards for a Getinge Sterilizer? – PowerPoint PPT presentation

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Title: STERILIZATION HEALTHCARE


1
STERILIZATIONHEALTHCARE
Steam Sterilizers Operation and Preventative
Maintenance
2
Sterilization Fundamentals
  • Sterilization A process by which all forms of
    microbial life including bacteria, viruses,
    spores, and fungi are destroyed
  • Note In a sterilization process, the nature of
    microbial death is described by an exponential
    function. Therefore, the presence of
    microorganisms on any individual item can be
    expressed in terms of probability. While this
    probability can be reduced to a very low number,
    it can never be reduced to zero. (ANSI/AAMI ST46)

3
General Terminology Review
Sterility Testing Product is inoculated directly
into growth medium. Process Monitoring Use of
mechanical, biological and chemical indicators to
monitor critical sterilization parameters.
Parametric release Declaring product sterile
based on records demonstrating that the process
parameters were delivered within specified
tolerances. This method does not include the use
of Biological Indicators.
4
General Terminology Review
  • Bio Burden
  • of microorganisms on a contaminated item
  • Reduction of Bio Burden
  • Hand washing soap and water
  • Chemical high level disinfection
  • Sanitization
  • Decontamination
  • Disinfection

5
What is a Steam Sterilizer ?
6
Technology Fundamentals
  • Steam sterilizers for healthcare have one primary
    purpose

Render instruments sterile for re-use in a
surgical setting
7
Sterilization Fundamentals
  • Steam Sterilizers
  • Temperatures ranging from 121-134?C at pressures
    of 15-30 psi are generally recommended to
    sterilize wrapped or unwrapped surgical
    instruments.
  • Why Steam?

Highly Effective
Easy to Control
Non Toxic
Readily Available
Inexpensive
8
Sterilization Fundamentals
Two Types of Steam Sterilizers Vacuum used for
large volumes of wrapped surgical
instruments Gravity used for individual
unwrapped surgical instruments
9
Sterilization Fundamentals
Alternate Sterilization Technologies ETO
(Ethylene oxide) Gas Plasma Ozone Dry Heat
Sterilizers
Low temp.
Ultra High temp.
10
Sterilization Fundamentals
  • Healthcare Steam Sterilizers
  • Typical Dimensions
  • 16 wide x 16" high x 16" long (gravity or
    vacuum)
  • 20 wide x 20" high x 38" long (gravity or
    vacuum)
  • 24 wide x 36" high x 36" long (usually vacuum)
  • 24 wide x 36" high x 48" long (usually vacuum)
  • 24 wide x 36" high x 60" long (usually vacuum)
  • Floor loader 26.5 x 62 x up to 76

small
medium
large
11
Sterilization Fundamentals
  • Steam Sterilizers
  • Smaller sterilizers instruments inserted
    individually for quick sterilization
  • Larger sterilizers (36" or larger) can hold
    entire carriage of instruments for sterilizing
  • Floor loader rises to floor level where entire
    cart and carriage of instruments are inserted
    for sterilization

12
Factors Affecting Sterilization
Sterilization Fundamentals
  • Time
  • Sterility Assurance Level (SAL) 10-6
  • One survivor out of a million (infectious
    organisms)
  • Temperature
  • 250F/270F/275F
  • Moisture
  • Required to coagulate protein
  • However, steam quality requires a maximum vapor
    content of 3

13
Steam Quality Through RO Water
Sterilization Fundamentals
  • Reverse-Osmosis (RO) the process of squeezing
    water through a semi-permeable membrane.
  • RO will separate pure water molecules from
    dissolved solids such as Calcium, Sodium and Iron
  • Chlorine, Nitrates and Nitrites are removed in
    the pre-filtration process.

14
Benefits of RO in Steam Generation ( Clean Steam)
Sterilization Fundamentals
  • Balances pH
  • Reduces downtime
  • Reduces costly repairs
  • Extends useful equipment life
  • Removes hardness
  • Improves equipment reliability

15
Other Factors Affecting Sterilization
Sterilization Fundamentals
  • Proper sterilizer design and use to achieve time
    and temperature
  • Sterilizer area design and quality utilities
    feeding unit
  • Bio Burden reduced prior to sterilization
  • Adequate contact of the sterilant for all
    surfaces

16
Sterilization Fundamentals
Why is air removal important?
  • Air and steam do not mix
  • Air inhibits steam contact
  • Air is 1.6 times denser than steam
  • Steam condenses on cool goods
  • Loading and load size
  • Packs must be dry

17
Sterilization Fundamentals
  • Decimal Reduction Value (D-Value)
  • The exposure to sterilant required to reduce the
    population of test organism by 90 (one
    logarithm) under stated conditions.
  • Sterility Assurance Level (SAL)
  • Probability of a non-sterile unit. As a minimum
    sterilization cycles are designed to provide a 1
    in a million chance of a non-sterile unit. SAL
    10-6

SAL
18
More about D-Value and SAL...
Sterilization Fundamentals
  • The SAL is extrapolated from the survivor curve
    based on the D-value of the Biological Indicator
    and exposure time.
  • Traditional cycle development is driven by
    determining the time for complete kill of a 106
    BI and double the cycle time to achieve SAL of
    10-6

19
Sterilization Fundamentals
  • 3 Primary Factors of Sterility Assurance
  • Process Control - Reproducible and controlled
    conditions
  • Process Monitoring - Biological indicators,
    chemical indicators, mechanical gauges, cycle
    charts or printouts, etc.
  • Good Manufacturing Practices (GMP) - Includes
    record keeping, inspection of materials, process
    validation and equipment maintenance and
    calibration

Complete sterility assurance can only be achieved
by testing each item processed - a destructive
and impractical procedure.
20
Sterilization Cycle Talk Getinge Vacuum Cycle
Sterilization Fundamentals
The actual sterilizer cycle as logged in our
digital software solution, T-Doc
21
Sterilizer Maintenance
  • Why should we have preventative maintenance on a
    sterilizer?
  • What happens in the sterilizer during a cycle?
  • What should I look for the start of my shift?
  • What can effect the sterilization process that I
    can control?
  • What can effect the sterilization process that I
    can not control directly?

22
Sterilizer Maintenance
  • Why should we have preventative maintenance on a
    sterilizer?
  • Keeps the machine running to manufactures
    recommended specifications
  • Minimizes the amount of downtime
  • Provides assurance that the unit is running
    optimally
  • Extends the life of the sterilizer
  • Ensures the unit is safe for operating- no
    chamber cracks, faulty valves etc
  • Ensures the appropriate sterility is met by the
    system as it was intended to provide at time of
    manufacturing

23
Sterilizer Maintenance
  • Sterilizer Video - What Happens during a
    sterilization cycle


24
Sterilizer Maintenance
  • What should I look for when start of my shift?
  • Ask the person who you are replacing if there
    have been any autoclave problems during their
    shift. Keep a log book of events for of date,
    time, unit number, copy of print out and what
    occurred.
  • Check gasket for wear and tear on the machines
    you are using
  • Check chamber and drains to ensure no paper or
    items are obstructing the drain
  • Check the printer paper to ensure you have enough
  • Verify you have appropriate materials for
    logging, biological tests and bowie dick tests if
    required for your shift
  • Check to see if youll be required to process
    stat loads etc during your work period to allow
    you to manage the flow

25
Sterilizer Maintenance
  • What can effect the sterilization process that I
    can control?
  • The proper loading and spacing of the sterilizer
    cart/trolley
  • Using the proper packaging material
  • Checking to ensure drain is not plugged and is
    cleaned at regular intervals
  • Cleaning of the chamber and carts at regular
    intervals
  • Proper cool down area away from air conditioning
  • Items being sterilized are dry, containers, blue
    silicone liners dry as well as plastic bowls etc
  • Being able to properly read the tests BD,
    Biological, Indicators, Integrators etc
  • Prequalification of the units after a major
    repair of the sterilizer

26
Sterilizer Maintenance
  • What can effect the sterilization process that I
    can not control directly?
  • The sterilizer malfunctioning
  • Steam supply staturation drops below 97
  • Water pressure drops
  • Electrical power failure
  • Failure of BD Test redo test and check results
    2nd failure contact service for repair
  • Consistently wet steam or dirty steam (tea
    effect) You can perform a warm-up prior to the
    bowie dick test and this will help remove as much
    moister from the lines as possible.
  • Dirty steam you can have filters placed at the
    feed of the units to filter out debris and some
    of the chemicals used by maintenance to clean the
    steam lines

27
Sterilization Fundamentals
Who establishes the proper sterilization
parameters for reusable medical devices?
Answer The responsibility for safe and
effective sterilization of reusable medical
devices is the shared responsibility of both
manufacturers, and users of the devices.
Reichert Young, p. 132
28
Summary - Key Learnings
  • Reviewed General Terminology
  • Reviewed the Sterilization Fundamentals
  • Reviewed Sterilizer Maintenance and areas that
    can be controlled by MDRD employee

29
Sterilizer Maintenance
Questions? Thank you for your Time
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